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Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02454972
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Brief Summary:
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs)

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: lurbinectedin (PM01183) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Study Start Date : August 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
Drug: lurbinectedin (PM01183)



Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).


Secondary Outcome Measures :
  1. Duration of response (DR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Duration of response (DR), defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.

  2. Progression free survival (PFS) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation.

  3. Overall survival (OS) in each cohort of advanced solid tumors [ Time Frame: From first infusion up to 12 months after last enrolled cohort patient received the first PM01183 infusion, except in SCLC cohort. SCLC patients will be assessed up to death, an average of 1 year is expected (cycle duration: 3 weeks) ]
    Defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cut-off established for the cohort.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Voluntary signed informed consent (IC)
  • Pathologically proven diagnosis of any of the following malignancies:

    • Small cell lung cancer (SCLC).
    • Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
    • Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
    • Biliary tract carcinoma.
    • Endometrial carcinoma.
    • BRCA 1/2- associated metastatic breast carcinoma
    • Carcinoma of unknown primary site.
    • Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
    • Ewing's family of tumors (EFTs)
  • Prior treatment. Patients must have received:

    • SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
    • H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
    • GCTs: no limit of prior therapy
    • EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
    • BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
  • Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
  • Adequate major organ function
  • At least three weeks since the last chemotherapy
  • Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry

Exclusion Criteria:

  • Prior treatment with PM01183 or trabectedin
  • Prior or concurrent malignant disease unless in complete remission for more than five years
  • Known central nervous system (CNS) involvement
  • Relevant diseases or clinical situations which may increase the patient's risk
  • Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454972


Contacts
Contact: PharmaMar Clinical Oncology Department clinicaltrials@pharmamar.com

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Sponsors and Collaborators
PharmaMar

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02454972     History of Changes
Other Study ID Numbers: PM1183-B-005-14
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018